A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence

Official Title ICMJE

Regulatory Post Marketing Surveillance of Intelence Tablet

Brief Summary

The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Detailed Description

This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of etravirine in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: Case-OnlyTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with etravirine for treatment of AIDS.

Condition ICMJE

Acquired Immune Deficiency Syndrome

Intervention ICMJE

Drug: No intervention

This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

Study Group/Cohort (s)

Etravirine

Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.

Intervention: Drug: No intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

7

Completion Date

July 2014

Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patients who are prescribed with etravirine for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion Criteria:

Known hypersensitivity to Intelence

Intelence coadministered with medicinal products that are highly dependent on CYP3A and CYP2C9 for clearance